度普利尤单抗治疗重度哮喘的快速卫生技术评估  

Dupilumab for the treatment of severe asthma:a rapid health technology assessment

作　　者：王华玉 董士超 孙伟 王莹[1] WANG Huayu;DONG Shichao;SUN Wei;WANG Ying(Dept.of Pharmacy,the Second Hospital of Tianjin Medical University,Tianjin 300211,China;Dept.of Respiratory,the Second Hospital of Tianjin Medical University,Tianjin 300211,China)

机构地区：[1]天津医科大学第二医院药学部,天津300211 [2]天津医科大学第二医院呼吸内科,天津300211

出　　处：《中国药房》2025年第6期648-654,共7页China Pharmacy

基　　金：四川省自然科学基金项目(No.2023NSFSC0526);天津医科大学第二医院青年科研基金项目(No.2023ydey30)。

摘　　要：目的采用快速卫生技术评估(HTA)的方法,评价度普利尤单抗治疗重度哮喘的有效性、安全性和经济性,为临床治疗提供循证依据。方法检索PubMed、Cochrane Library、中国知网、万方和维普网等数据库及HTA机构官网,收集度普利尤单抗治疗重度哮喘的HTA报告、系统评价/Meta分析和药物经济学研究。筛选文献、提取数据并评估文献质量后,对文献结果进行描述性分析。结果共纳入15篇文献,包括9篇系统评价/Meta分析和6篇药物经济学研究。有效性方面,度普利尤单抗显著优于安慰剂。与其他生物制剂比较,在12岁及以上的重度哮喘患者中,对于嗜酸性粒细胞(EOS)≥300个/μL的人群,度普利尤单抗改善第1秒用力呼气容积(FEV1)的作用排第1位,优于特泽鲁单抗、贝那利珠单抗和美泊利珠单抗;减少哮喘急性发作的作用排第2位,仅次于特泽鲁单抗;而改善哮喘控制问卷评分的作用排名比较靠后,仅优于贝那利珠单抗。对于150个/μL≤EOS<300个/μL的人群,度普利尤单抗对哮喘急性发作的改善情况优于美泊利珠单抗,而对FEV1的改善作用弱于贝那利珠单抗和美泊利珠单抗。安全性方面,度普利尤单抗与安慰剂及其他生物制剂的不良事件和严重不良事件发生率的差异无统计学意义,但其注射部位反应的发生率显著高于安慰剂。经济性方面,各国研究结果不一致,尚缺乏我国的研究数据。结论度普利尤单抗用于重度哮喘具有良好的有效性和安全性,经济性有待基于我国医疗环境进一步研究。OBJECTIVE To evaluate the efficacy,safety and cost-effectiveness of dupilumab in the treatment of severe asthma with rapid health technology assessment(HTA),and to provide evidence-based evidence for clinical treatment.METHODS Retrieved from PubMed,Cochrane Library,CNKI,Wanfang,VIP database,and other related websites of HTA.HTA reports,systematic review/meta-analysis,and economic studies of dupilumab in the treatment of severe asthma were collected.Researchers independently identified literature,extracted data,and assessed the quality of included studies.Qualitative description was performed.RESULTS A total of 15 pieces of literature were included,involving 9 systematic reviews/meta-analyses and 6 economic studies.In terms of effectiveness,dupilumab was significantly better than placebo.Compared with other biological drugs,in the patients with severe asthma aged 12 years and above,for those with eosinophil(EOS)≥300 cells/μL,dupilumab ranked first in improving forced expiratory volume in one second(FEV1),outperforming tezepelumab,benralizumab,and mepolizumab.It ranked second in reducing acute exacerbations,surpassed only by tezepelumab,while its effect on improving asthma control questionnaire score was relatively lower,being better only than benralizumab.For those with 150 cells/μL≤EOS<300 cells/μL,dupilumab was superior to mepolizumab in reducing asthma exacerbation,while the effect on FEV1 was weaker than benralizumab and mepolizumab.In terms of safety,there was no significant difference in the incidence of adverse events and serious adverse events between dupilumab and placebo or other biological drugs,while the incidence of injection site reactions of dupilumab was significantly higher than placebo.In terms of cost-effectiveness,the research results of different countries were not consistent,and there was a lack of research data from China.CONCLUSIONS Dupilumab is an effective and safe choice in the treatment of severe asthma,and its cost-effectiveness requires further research based on China’s medic

关 键 词：度普利尤单抗 重度哮喘 快速卫生技术评估 有效性 安全性 经济性 

分 类 号：R974.3[医药卫生—药品] R562.25[医药卫生—药学] R969.3